DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the amendment filed on July 30th, 2025. Per the amendment, claims 1, 5, 8, 10-12, and 14 are as currently amended; claims 7 and 9 are previously presented; and claims 2-4, 6, 13, and 15 are canceled. Claims 1, 5, 7-12, and 14 are currently pending in the instant application.
All claim objections are rejections pursuant to 35 U.S.C. 112(b) made in the Non-Final Rejection mailed on May 6th, 2025, are withdrawn in light of the amendments. The drawing objection made in the Non-Final Rejection mailed on May 6th, 2025, is sustained and is not withdrawn.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the nozzle of the nebulizer must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. EXAMINER NOTE: The Examiner acknowledges a nozzle is a feature that is an inherent part of a nebulizer as explained by Applicant in remarks filed on July 30th, 2025 (Pg. 5). Further, the Examiner agrees with Applicant and acknowledges reference numeral “42” of Fig. 1 designates the nebulizer (Pg. 5 of Applicant remarks; nebulizer 42 is a square within airpipe 2, see annotated Fig. 1 below). However, there is no structure connecting, corresponding, or protruding from the nebulizer (42) in Fig. 1 to represent the nozzle of the nebulizer. Further, claim 7 recites “a nozzle diameter of the nebulizer” (lines 1-2), hence the nozzle of the nebulizer is a feature of the invention specified in the claims (claim 7). While the nozzle of the nebulizer may be “schematically represented as a part of the nebulizer” in Figure 1, a supplementary figure showing the nozzle of the nebulizer is not provided. Therefore, the nozzle of the nebulizer, a feature of the invention specified in claim 7, is not shown in Fig. 1 or in any of the additional drawings filed by Applicant (See MPEP §608.02d).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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Annotated Fig. 1
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12, line 2: “a patient’s nose” should read “a nose of the patient” for consistency and clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 5, 8-10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Papania et al. (US 20130072755 A1), in view of Kuenen et al (US 20180206813 A1), in further view of Duffy et al. (US 20200368483 A1), and in further view of Denyer et al. (WO 2004045690 A1).
Regarding claim 1, Papania discloses a respiratory drug delivery device (nasal delivery device 10; Fig. 1A) for delivering a drug to respiratory tract of a patient ([0080], lines 8-10), comprising:
an inhalation part (nasal prong 14; Fig. 1A);
an air pipe (base member 20, connecting portion 19; Fig. 1A), being connected to the inhalation part (nasal prong 14; Fig. 1A; [0080], lines 12-13);
a sound sensor (activation member 22; Fig. 1A), being disposed on an inner surface or an outer surface of the air pipe (outer surface of base member 20, outer surface of connecting portion 19, see Fig. 1A; [0083], lines 1-2) for detecting a wind shear from a breath of the patient ([0085], lines 1-3)and generating a sound signal (0103], lines 5-6, where the activation member 22 comprises a microphone, [0085], line 1).
Papania does not explicitly disclose the sound signal (activation signal from activation member 22; [0103], lines 5-6) comprises a plurality of breathing cycles, each of the breathing cycles sequentially includes an inhalation section, a pause section, and an exhalation section, and wherein the drug delivery module outputs the nebulized drug at 0.1 to 5 seconds before the beginning of the inhalation section until 0.5 to 3 seconds before the end of the inhalation section.
However, Kuenen teaches a system and method for analysis of the respiratory system comprising a microphone signal to detect including a plurality of breathing cycles ([0101], lines 1-3) over a period of time ([0070], lines 2-3); wherein the microphone signal is used to determine the timing of different phases of the patient’s breathing cycle ([0101]). Kuenen further teaches each of the breathing cycles ([0101], lines 1-3, where the microphone sounds are the recordings of at least one breathing cycle) sequentially includes an inhalation section (the inspiratory phase, [0102], line 6), a pause section (inspiratory pause, [0102], line 6), and an exhalation section (expiratory phase, [0102], line 7). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Papania with Kuenen such that the sound signal (activation signal from activation member 22; [0103], lines 5-6) comprises a plurality of breathing cycles (Kuenen: [0101], lines 1-3; [0070], lines 2-3), each of the breathing cycles (Kuenen: [0101], lines 1-3, where the microphone sounds are the recordings of at least one breathing cycle) sequentially includes an inhalation section (Kuenen: the inspiratory phase, [0102], line 6), a pause section (Kuenen: inspiratory pause, [0102], line 6), and an exhalation section (Kuenen: expiratory phase, [0102], line 7) to monitor the changes in airflow from one breath cycle to the next and provide treatment to the user when suitable (Kuenen: [0084]).
Kuenen is silent to outputting the nebulized drug at 0.1 to 5 seconds before the beginning of the inhalation section until 0.5 to 3 seconds before the end of the inhalation section.
However, Duffy teaches an aerosolization system for delivering a dose of a nebulized drug to a patient’s respiratory system that the nebulized drug 0.5 seconds before inhalation ([0083], lines 8-12). The output of the nebulized drug 0.5 seconds before inhalation, as taught by Duffy, is within the 0.1 to 5 seconds before the beginning of inhalation that is disclosed in the claimed invention; therefore, Duffy is within the claimed range of 0.1 to 5 seconds before the beginning of inhalation. Hence, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Papania with Duffy such that the drug delivery module (circuit board 120, Fig. 11; nebulizing device 80, Fig 5) outputs the nebulized drug (treatment agent after being nebulized; [0090], lines 7-8) at 0.1 to 5 seconds before a beginning of the inhalation section (Kuenen: the inspiratory phase, [0102], line 6; Duffy: [0083], lines 8-12) to increase treatment effectiveness by timing the creation of the aerosol (Duffy: [0080], lines 1-3).
Duffy is silent to outputting the nebulized drug until 0.5 to 3 seconds before the end of the inhalation section.
However, Denyer teaches aerosol delivery from a respiratory drug delivery device ceases at least 0.5 seconds before a person is expected to stop inhaling (Pg. 4, lines 7-8); therefore, Denyer is within the claimed range of 0.5 to 3 seconds before the end of the inhalation section. Hence, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Papania with Denyer such that the drug delivery module (circuit board 120, Fig. 11; nebulizing device 80, Fig 5) outputs the nebulized drug (treatment agent after being nebulized; [0090], lines 7-8) at 0.1 to 5 seconds before the beginning of the inhalation section (Kuenen: the inspiratory phase, [0102], line 6; Duffy: [0083], lines 8-12) until 0.5 to 3 seconds before the end of the inhalation section (Denyer: Pg. 4, lines 7-8) to reduce drug treatment time (Denyer: Abstract).
Regarding claim 5, Papania as modified further teaches the claimed invention as set forth in claim 1, wherein the nebulized drug (treatment agent after being nebulized; [0090], lines 7-8) is at least a nebulized micronized drug, a nebulized water-soluble drug, or a nebulized drug suspension ([0096], lines 3-10, where the treatment agent is the drug to be nebulized).
Regarding claim 8, Papania as modified further teaches the claimed invention as set forth in claim 5, wherein the nebulizer (nebulizing device 80; Fig. 5) is an ultrasonic vibrating atomizer (description of nebulizing device 80 as an ultrasonic nebulizer, [0097]).
Regarding claim 9, Papania as modified further teaches the claimed invention as set forth in claim 1, wherein the inhalation part (nasal prong 14; Fig. 1A) is a nasal mask, an oronasal mask, or a nasal catheter (nasal prong 14, see [0080], lines 8-10, where the delivery device 10 can be configured to be a single-naris or a dual-naris device, [0120], lines 1-3).
Regarding claim 10, Papania as modified teaches a method for automating drug delivery to a respiratory system ([0002]), comprising:
step (1): providing a respiratory drug delivery device (nasal delivery device 10; Fig. 1A), comprising an inhalation part (nasal prong 14; Fig. 1A); an air pipe (base member 20, connecting portion 19; Fig. 1A) being connected to the inhalation part (nasal prong 14; Fig. 1A; [0080], lines 12-13); a sound sensor (activation member 22; Fig. 1A); a sound sensor being disposed on an inner surface or an outer surface of the air pipe (Fig. 1A; [0083], lines 1-2); and a drug delivery module (circuit board 120, Fig. 11; nebulizing device 80, Fig. 5) comprising a nebulizer (nebulizing device 80; Fig. 5) for nebulizing a drug into a nebulized drug ([0090], lines 7-8, where a nebulizing device is nebulizing device 80) and outputting the nebulized drug (treatment agent after being nebulized; [0090], lines 7-8) to the air pipe (base member 20, connecting portion 19; treatment agent is nebulized once passing through opening 54 and is retained in connection part 19 before passing through nasal prong 14, see Fig. 3; [0091], lines 4-9; [0080], lines 14-16);
step (2): detecting a wind shear from a breath of a patient (0085], lines 1-3) and generating a sound signal (activation signal from activation member 22) using the sound sensor ([0103], lines 5-6, where the activation member 22 comprises a microphone, [0085], line 1); and
step (3): determining a breathing cycle of the patient from the sound signal (activation signal from activation member 22; Kuenen: [0101]), wherein the sound signal (activation signal from activation member 22; [0103], lines 5-6) comprises a plurality of breathing cycles (Kuenen: [0101], lines 1-3; [0070], lines 2-3), each of the breathing cycles (Kuenen: [0101], lines 1-3, where the microphone sounds are the recordings of at least one breathing cycle) sequentially includes an inhalation section (Kuenen: the inspiratory phase, [0102], line 6), a pause section (Kuenen: inspiratory pause, [0102], line 6), and an exhalation section (Kuenen: expiratory phase, [0102], line 7); outputting the nebulized drug (treatment agent after being nebulized; [0090], lines 7-8) to the air pipe (base member 20, connecting portion 19; treatment agent is nebulized once passing through opening 54 and is retained in connection part 19 before passing through nasal prong 14, see Fig. 3; [0091], lines 4-9; [0080], lines 14-16) at 0.1 to 5 seconds before the beginning of the inhalation section (Kuenen: the inspiratory phase, [0102], line 6; Duffy: [0083], lines 8-12) until 0.5 to 3 seconds before the end of the inhalation section (Denyer: Pg. 4, lines 7-8).
Papania as modified does not explicitly teach the method of collecting a respiratory flow (respiratory flow of the subject; [0081], line 12) with the air pipe (base member 20, connecting portion 19; Fig. 1A) through the inhalation part (nasal prong 14; Fig. 1A).
However, Kuenen further teaches the step of a passageway collecting air flow from a user’s breath wherein the opening the user’s breath travels through is the inhalation part (see Fig. 1; [0028], lines 1-5). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Papania with Kuenen to include the method of collecting a respiratory flow (respiratory flow of the subject; [0081], line 12) with the air pipe (base member 20, connecting portion 19; Fig. 1A) through the inhalation part (nasal prong 14; Fig. 1A; Kuenen: passageway collects air flow from user's breath where the opening the user breaths moves in and out of is the inhalation part, see Fig. 1; [0028], lines 1-5) to ensure the patient's breath passes from the inhalation to the air pipe where the sound sensor is located so the wind shear can be effectively detected (Kuenen: [0047]-[0048]).
Regarding claim 14, Papania as modified above further teaches the claimed invention as set forth in claim 13, in step (3), the drug delivery module (circuit board 120, Fig. 11; nebulizing device 80, Fig 5) outputs the nebulized drug (treatment agent after being nebulized; [0090], lines 7-8) at 0.1 to 5 seconds before a beginning of the inhalation section (Kuenen: the inspiratory phase, [0102], line 6; Duffy: [0083], lines 8-12) until an end of the inhalation section (Kuenen: the inspiratory phase, [0102], line 6; Duffy: [0042], line 2).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Papania et al. (US 20130072755 A1), in view of Kuenen et al (US 20180206813 A1), in view of Duffy et al. (US 20200368483 A1), in view of Denyer et al. (WO 2004045690 A1) as applied above, and further in view of Xu (US 20160130715 A1).
Regarding claim 7, Papania as modified above further teaches the claimed invention as set forth in claim 5, a nozzle diameter (diameter of apertures in mesh 56; Fig. 3) of the nebulizer (nebulizing device 80; Fig. 5), but does not explicitly disclose the nozzle diameter (diameter of apertures in mesh 56; Fig. 3) of the nebulizer (nebulizing device 80; Fig. 5) is below 10 µm.
However, Xu teaches an apparatus and method for aerosolizing a liquid comprising a mesh aperture plate for a liquid nebulizer wherein the apertures are the openings in the mesh and have an exit opening with a diameter from 0.5 µm to 6 µm ([0033], lines 1-3; [0049], lines 1-4); therefore, Xu is within the claimed range of below 10 µm. Hence, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Papania with Xu such that , a nozzle diameter (diameter of apertures in mesh 56; Fig. 3) of the nebulizer (nebulizing device 80; Fig. 5) is below 10 µm (Xu: [0033], lines 1-3; [0049], lines 1-4) to deliver a fine mist of aerosol to the patient for effective drug delivery to the respiratory system (Xu: [0003], lines 1-4; [0092], lines 16-17).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Papania et al. (US 20130072755 A1), in view of Kuenen et al (US 20180206813 A1), in view of Duffy et al. (US 20200368483 A1), in view of Denyer et al. (WO 2004045690 A1) as applied above, and further in view of Nam et al. (Y. Nam, B. A. Reyes and K. H. Chon, "Estimation of Respiratory Rates Using the Built-in Microphone of a Smartphone or Headset," Nov. 2016, IEEE Journal of Biomedical and Health Informatics, vol. 20, no. 6, pp. 1493-1501.).
Regarding claim 11, Papania as modified above further teaches the claimed invention as set forth in claim 10, but fails to teach in step (2), a respiratory frequency of the patient is 0.2 to 1 Hz.
However, Nam teaches an estimation of respiratory rates using a built-in microphone of a smartphone or headset comprising a collection of subjects’ breathing frequencies ranging from 0.1 Hz to 1.5 Hz (Pg. 3, last paragraph, lines 5-6). The range set forth by Nam partially overlaps with the claimed range; therefore, Nam is within the claimed range of 0.2 Hz to 1 Hz. Hence, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Papania with Nam such that in step (2), a respiratory frequency of the patient is 0.2 to 1 Hz (Nam: Pg. 3, last paragraph, lines 5-6) to cover the respiratory frequency for low, average, and high breathing ranges (Nam: Pg. 7, first paragraph of Discussion and Conclusion section, lines 16-17).
Regarding claim 12, Papania as modified above further teaches the claimed invention as set forth in claim 11, in step (2), the respiratory flow (respiratory flow of the subject; [0081], line 12) is generated from a patient's nose (subject inhales through nose, [0082], lines 17-18; subject may exhale from nose, [0119], line 7) and delivered to the air pipe (base member 20, connecting portion 19; Kuenen: passageway collects air flow from user's breath where the opening the user breaths moves in and out of is the inhalation part, see Fig. 1; [0028], lines 1-5).
Response to Arguments
Applicant's arguments filed July 30th, 2025, have been fully considered but they are not persuasive.
On page 6, Applicant argues “the cited references, individually or in combination, fail to disclose or render obvious the unique technical features and synergistic effects of the claimed invention, particularly the specific configuration of the sound sensor and nebulizer, the precise timing of drug delivery, and the resulting significant improvement in drug delivery efficiency”. Further, on page 7, Applicant argues “[t]he cited references, whether individually or in combination, fail to render the present invention obvious” and provides a detail explanation of what each cited reference teaches, or fails to teach, in relation to the spatial configuration and timing control features of the present invention (see Pg. 7 of Remarks). However, this explanation and analysis of the cited references does not consider the features of said cited references in combination as detailed in the Non-Final Office Action (mailed May 6th, 2025), but considers the features of the cited references separately and individually. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On page 7, Applicant explains how Papania differs from the present invention, specifically in relation to the configuration and position of the sound sensor within the air pipe, in which the said feature of the present invention is supported by paragraph [0032] of the present specification. Applicant argues “[n]one of the cited references – Papiania, Denyer, Kuenen, Duffy, Xu, or Nam-disclose or suggest this specific configuration”. The claim limitations regarding the configuration and placement of the sound sensor in relation to the air pipe recite “a sound sensor, being disposed on an inner surface or an outer surface of the air pipe” (claim 1, line 5) and “a sound sensor being disposed on an inner surface or an outer surface of the air pipe” (claim 10, lines 4-5), which are both “or” statements. When examining an “or” statement, a cited reference reads on the entire statement if one limitation is disclosed or suggested by the cited reference (see MPEP §2111.01). While Papania does not disclose a sound sensor disposed on an inner surface of the air pipe, Papania does disclose a sound sensor disposed on an outer surface of the air pipe (see claims 1 and 10 above). Hence Papania does disclose the claim limitation of “a sound sensor being disposed on an inner surface or an outer surface of the air pipe” (see claims 1 and 10 above).
As stated above, Applicant referenced paragraph [0032] of the present specification (see Pg. 7 of Remarks) as support for the configuration of the sound sensor within the air pipe of the present invention; however, the specification filed on April 5th, 2022, does not include paragraph numbers, hence it is unclear what paragraph is being referred to. Further, paragraph [0032] of the PGPub of the present invention (US 20230059539 A1) does not disclose the configuration of the sound sensor within the air pipe (see Fig. 1 below).
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Fig. 1. Screenshot of paragraph [0032] of US 20230059539 A1
On page 7, Applicant argues “[t]he cited references do not teach or suggest” the specific spatial configuration of the nebulizer positioned away from the inhalation part and the sound sensor. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the specific spatial configuration of the nebulizer positioned away from the inhalation part and the sound sensor) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally, Applicant cited paragraph [0040] of the present specification to support the specific spatial configuration of the nebulizer positioned away from the inhalation part and the sound sensor; however, the specification filed on April 5th, 2022, does not include paragraph numbers, and paragraph [0040] of the PGPub of the present invention (US 20230059539 A1) does not disclose the position of the nebulizer away from the inhalation part and the sound sensor (see Fig. 2 below); therefore, it is unclear what paragraph of the specification is being referred to.
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Fig. 2. Screenshot of paragraph [0040] of US 20230059539 A1
On page 8, Applicant argues “neither [Duffy or Denyer] discloses the full timing range or its combination with the specific sensor and nebulizer configuration”. While the Examiner agrees with this statement, Duffy does teach outputting nebulized drug from 0.1 to 5 seconds before the inhalation section (see claims 1 and 10 above) and Denyer teaches ceasing drug delivery 0.5 seconds before the end of inhalation (see claims 1 and 10 above). Further, there is motivation to combine both Duffy (“…to increase treatment effectiveness by timing the creation of the aerosol”; Duffy: [0080], lines 1-3; see claim 1 above) and Denyer (“…to reduce drug treatment time”; Denyer: Abstract; see claim 1 above) with Papania; therefore, the result of outputting nebulized drug from 0.1 to 5 seconds before the inhalation section until 0.5 to 3 seconds before its end would be routine optimization with the combination of Duffy, Denyer, and Papania discussed in claims 1 and 10 above (MPEP §2144.05.II).
On page 8, Applicant argues “the intermittent drug delivery mode, enabled by the claimed configuration and timing, achieves a delivery efficiency of 50-75%, compared to 20-40% for continuous delivery modes. This 2- to 3-fold improvement is a significant, non-obvious advancement over the prior art, which the cited references neither disclose nor suggest”. The present specification does disclose the intermittent drug delivery mode, enabled by the claimed configuration and timing, achieves a delivery efficiency of 50-75% ([0043] of US 20230059539 A1), but fails to disclose continuous delivery modes have a delivery efficiency of 20-40%. The present specification does disclose “[o]n average, only 20% to 30% of the aerosol drug enters into the patient's body through the respiratory system” ([0003] of US 20230059539 A1). Hence, it is unclear if the “2- to 3-fold improvement” of the present invention is an accurate calculation. Further, the 50-75% drug delivery efficiency of the present invention and the 2- to 3-fold improvement of the drug delivery of the present invention compared to continuous delivery modes are not disclosed in the pending claim. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the 50-75% drug delivery efficiency of the present invention and the 2- to 3-fold improvement of the drug delivery of the present invention compared to continuous delivery modes) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
On page 8, Applicant argues “[t]he combination of these references requires hindsight to arrive at the claimed invention”. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
On page 8, Applicant argues “[n]o reference or combination thereof discloses the specific configuration of the sound sensor within the air pipe, the nebulizer away from the inhalation part and sound sensor, or the precise drug delivery timing synchronized with the inhalation phase. Moreover, the significant improvement in drug delivery efficiency (50-75%) is an unexpected result that a person of ordinary skill in the art would not have predicted from the cited references”. However, the cited references in combination do discloses the specific configuration of the sound sensor in relation to the air pipe as disclosed in claims 1 and 10 (see above explanation; see claims 1 and 10 above) and the precise drug delivery timing synchronized with the inhalation phase (see claims 1 and 10 above). Additionally, the nebulizer away from the inhalation part and sound sensor and the significant improvement in drug delivery efficiency (50-75%) are not disclosed in the pending claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, the technical features of the amended claims of the present application are obvious over Papania, Denyer, Kuenen, Duffy, Xu, and Nam (see claims 1, 5, 7-12, and 14 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Edenhoffer (US 20200324062 A1): Regarding an inspiration device for the delivery of medicaments, where a nebulizer is configured to cease delivery of a drug prior to the end of inspiration.
Haartsen et al. (US 20120291779 A1): Regarding an aerosol delivery system configured to coordinate the output of a drug with a patient’s breathing cycle.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAYLE DALE whose telephone number is (571)272-1080. The examiner can normally be reached Monday-Friday from 8:45am to 5:45pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785